FOR IMMEDIATE RELEASE
HSG Begins Phase IIb Study in Huntington Disease (HD)
December 2, 2008 – The Huntington Study Group (HSG) is conducting a clinical trial in HD, “A multi-center, North American, randomized, double-blind, parallel group study comparing three doses of ACR16 versus placebo for the symptomatic treatment of Huntington disease” (HART) with the research medication ACR16. The HSG is a not-for-profit group of physicians and other clinical researchers who are experienced in the care of Huntington disease patients and dedicated to clinical research of Huntington disease. This study is sponsored by NeuroSearch (NEUR), www.neurosearch.com.
Huntington disease (HD) is an inherited neurodegenerative disease characterized by brain cell death that usually begins between the ages of 30 to 50, and includes motor, cognitive and behavioral signs and symptoms. While there are medications to help relieve some of the disease symptoms, there is no known treatment to slow the progression of HD, which affects about 30,000 people in both North America and Europe.
ACR16 belongs to a novel class of agents called dopaminergic stabilizers, which have the ability to either enhance or inhibit dopamine controlled functions depending on the initial level of dopaminergic activity. ACR16 was previously evaluated in four clinical Phase I/II studies for patients with Huntington disease, Parkinson disease and psychosis, and demonstrated a good safety and tolerability profile. In a Phase II study with ACR16 in Huntington disease, the results showed that 28 days of treatment with ACR16 led to an improvement in the patients’ voluntary movements, including parkinsonism and gait function.
In the current study participants will receive two daily doses of either 10mg, 22.5mg, or 45mg of ACR16 or matching placebo, to evaluate the efficacy and safety of ACR16 over a treatment period of three months. The primary measure of the study will be the effect of ACR16 on Huntington disease patients’ voluntary motor function measured by the modified Motor Score (mMS), a subscale of the Unified Huntington’s Disease Rating Scale (UHDRS). Secondary endpoints include the overall clinical impression of the subjects, cognitive function, and psychiatric symptoms such as depression and anxiety. NeuroSearch is a biopharmaceutical company with locations in Ballerup, Denmark and Gothenburg, Sweden seeking to develop new drugs for the treatment of disorders that affect the Central Nervous System and primarily through the modulation of ion channels and monoamine transporters. NeuroSearch has recently been listed as a ‘Top 10’ European biotech company with many candidate drugs moving into the late development phases.
For more information regarding this study please visit http://clinicaltrials.gov
HUNTINGTON STUDY GROUP
For more information, contact: